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KR-102961161-B1 - Human Biomonitoring Database System and Construction Method Thereof

KR102961161B1KR 102961161 B1KR102961161 B1KR 102961161B1KR-102961161-B1

Abstract

A human biomonitoring database system according to one embodiment of the present invention may include: a collection module that collects research information including an analytical instrument and analysis conditions for evaluating a participant's exposure to a harmful substance and a biomarker which is an exposure indicator by said harmful substance or a metabolite of a harmful substance, and participant information including survey response data in which personal details of said participant and dietary survey result information of said participant are investigated based on a sample collected from a participant in human biomonitoring and a web-based survey; a sample analysis management module that collects a sample from said sample, analyzes said biomarker from said sample under said analytical instrument and analysis conditions to evaluate the level of exposure to the harmful substance of an individual or population group, and assigns a label to said biomarker regarding the source and attributes according to said participant's survey response data; a normalization module that maps said research information, participant information, and the concentration of said harmful substance or metabolite of a harmful substance collected from said participant to at least one of a plurality of pre-set codes; and a database that stores the concentration of said harmful substance or metabolite of a harmful substance collected from said participant derived through the analysis of said research information, participant information, and said biomarker.

Inventors

  • 이헌주
  • 박승영
  • 이근영
  • 이혜영

Assignees

  • 켐아이넷(주)
  • 대한민국 (식품의약품안전처장)

Dates

Publication Date
20260511
Application Date
20251128

Claims (10)

  1. A collection module for collecting participant information including research information comprising analytical instruments and analytical conditions for evaluating a participant's exposure to hazardous substances and biomarkers that are exposure indicators by said hazardous substances or metabolites of said hazardous substances, and survey response data in which the participant's personal information and dietary survey result information are investigated based on samples collected from a participant in human biomonitoring and a web-based survey; A sample analysis management module that, after collecting a sample from the above sample, analyzes the biomarker from the sample under the above analytical instrument and analysis conditions to evaluate the level of exposure to hazardous substances of an individual or population, and assigns labels to the biomarker regarding the source and attributes according to the participant's survey response data; A normalization module that maps the above research information and participant information, and the concentration of hazardous substances or hazardous substance metabolites collected from the participants, to at least one of a plurality of preset codes; and A database storing the concentration of harmful substances or harmful substance metabolites collected from the participants derived through the analysis of the above-mentioned research information, participant information, and the above-mentioned biomarkers; comprising The above research information is, Includes a digital questionnaire used to assess participants' exposure to the above hazardous substances, The above participant information is, It includes survey response data generated by the above participant completing a digital questionnaire that matches the digital questionnaire of the above research information, and The above digital questionnaire is, It includes questions in the sections regarding personal information and dietary surveys, Based on the survey response to the above questions, it includes the personal information and dietary survey result information of the above participant, and The above personal information is, Includes the gender information, age information, household member information, residential area information, residential environment information, lifestyle pattern information, and health status information of the above-mentioned participant, and The above health status information is, It includes the disease and drug history of the above-mentioned participant, and The above sample analysis management module is, In conjunction with the integrated risk assessment system for hazardous substances, derive results of an assessment of exposure levels to hazardous substances for individuals or populations that include predicted values regarding the likelihood of disease occurrence and health effects for individuals or populations, and The integrated risk assessment system for the aforementioned hazardous substances is, A human biomonitoring database system characterized by predicting the likelihood of disease occurrence and health effects of an individual or population group by using the concentration of harmful substances or metabolites of harmful substances collected from the participant derived through the analysis of the above biomarkers, and the above health status information, while applying variables of personal information excluding the above health status information as correction variables.
  2. In Article 1, The above-mentioned multiple pre-configured codes are, A human biomonitoring database system characterized by MIMS (Master Index of Monitoring Substances), MAP (Monitoring of Atmospheric Pollutants), HBM4EU (Human Biomonitoring for Europe), LOINC (Logical Observation Identifiers Names and Codes), UCUM (Unified Code for Units of Measure), and HL7 FHIR Consent.
  3. In Article 2, An input module for inputting at least one code among the above-mentioned preset codes; and A human biomonitoring database system further comprising: an output module that outputs at least one of the research information, participant information, and the concentration of harmful substances or harmful substance metabolites collected from the participant, mapped to the code input in the input module.
  4. In Paragraph 3, The above output module is, A human biomonitoring database system characterized by visualizing the results of the assessment of exposure levels to hazardous substances of the individual or population group and outputting them in the form of a dashboard, and transmitting the results of the assessment of exposure levels to hazardous substances of the individual or population group in the form of a report to at least one of the participant and an external organization.
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  10. a) A step in which a collection module collects participant information including research information comprising analytical instruments and analytical conditions for evaluating a participant's exposure to a hazardous substance and biomarkers that are exposure indicators by said hazardous substance or metabolites, and survey response data in which the participant's personal information and dietary survey result information are investigated based on samples collected from a participant in human biomonitoring and a web-based survey; b) A step in which a sample analysis management module collects a sample from the sample, analyzes the biomarker from the sample under the analytical instrument and analysis conditions, and evaluates the level of exposure to hazardous substances of an individual or population; c) A step in which the sample analysis management module assigns labels to the biomarkers regarding the source and attributes according to the participant's survey response data; d) a step in which a normalization module maps the research information and participant information, and the concentration of hazardous substances or hazardous substance metabolites collected from the participants, to at least one of a plurality of preset codes; and e) a step in which the database stores the research information, participant information, and the concentration of hazardous substances or hazardous substance metabolites collected from the participants; and The above research information is, Includes a digital questionnaire used to assess participants' exposure to the above hazardous substances, The above participant information is, It includes survey response data generated by the above participant completing a digital questionnaire that matches the digital questionnaire of the above research information, and The above digital questionnaire is, It includes questions in the sections regarding personal information and dietary surveys, Based on the survey response to the above questions, it includes the personal information and dietary survey result information of the above participant, and The above personal information is, Includes the gender information, age information, household member information, residential area information, residential environment information, lifestyle pattern information, and health status information of the above-mentioned participant, and The above health status information is, It includes the disease and drug history of the above-mentioned participant, and The above sample analysis management module is, In conjunction with the integrated risk assessment system for hazardous substances, derive results of an assessment of exposure levels to hazardous substances for individuals or populations that include predicted values regarding the likelihood of disease occurrence and health effects for individuals or populations, and The integrated risk assessment system for the aforementioned hazardous substances is, A method for constructing a human biomonitoring database system characterized by using the concentration of harmful substances or metabolites of harmful substances collected from the participant derived through the analysis of the above biomarkers, and the above health status information, while applying variables of personal information excluding the above health status information as correction variables to predict the likelihood of disease occurrence and health effects of an individual or population group.

Description

Human Biomonitoring Database System and Construction Method Thereof The present invention relates to a human biomonitoring database system and a method for constructing the same, and more specifically, to a human biomonitoring database system and a method for constructing the same that efficiently stores and manages data necessary to evaluate a participant's exposure to harmful substances from samples collected from a participant in human biomonitoring by normalizing the data. Currently conducted Human Biomonitoring (HBM) is utilized to assess exposure levels to hazardous substances by collecting and analyzing human samples such as blood, urine, tissues, DNA, and RNA. However, as research is carried out in a decentralized manner on an individual research basis, results are accumulated in a fragmentary manner, and there are limitations in the integrated management of sample collection and analysis findings. Consequently, it is difficult to provide reliable information to researchers, policymakers, and the public. In particular, the current HBM system faces multiple problems, including the absence of an integrated management platform for sample collection and analysis results, a lack of visualization systems to intuitively verify individual exposure indicators and population-level statistical results, and insufficient digital infrastructure to ensure data sharing and interoperability among researchers and institutions. Furthermore, as various types of research data collected within the HBM system are entered by multiple administrators using different names, abbreviations, numbers, and symbols, research data that cannot be retrieved from the database occurs. Consequently, there is a problem where the accuracy of exposure assessments is compromised due to the omission of research data when conducting future assessments based on it. Accordingly, the applicant intends to develop a human biomonitoring database system and a method for constructing the same, which enables the efficient storage and management of data necessary to evaluate participants' exposure to hazardous substances by normalizing it, in order to evaluate participants' exposure to hazardous substances in conjunction with the correlation analysis system between environmental hazardous factors and specific diseases, which is a technical feature of a previously filed patent. FIG. 1 is a block diagram illustrating the components of a human bio-monitoring database system according to one embodiment of the present invention. FIG. 2 is a block diagram illustrating the components of a collection module according to one embodiment of the present invention. Figure 3 is a diagram illustrating an example of a questionnaire for collecting survey response data from participants. Figure 4 is a diagram illustrating the types of questionnaires. FIG. 5 is a block diagram illustrating additional components of a human bio-monitoring database system according to one embodiment of the present invention. FIG. 6 is a block diagram illustrating the types of output data output from an output module according to an embodiment of the present invention. FIG. 7 is a diagram illustrating an example of first output data. FIG. 8 is a flowchart illustrating a method for constructing a human bio-monitoring database system according to an embodiment of the present invention. Hereinafter, embodiments of the present invention are described in detail with reference to the attached drawings so that those skilled in the art can easily implement the present invention. However, since the description of the present invention is merely an example for structural or functional explanation, the scope of the present invention should not be interpreted as being limited by the embodiments described in the text. That is, since the embodiments are subject to various modifications and may take various forms, the scope of the present invention should be understood to include equivalents capable of realizing the technical concept. Furthermore, the objectives or effects presented in the present invention do not imply that a specific embodiment must include all of them or only such effects; therefore, the scope of the present invention should not be understood as being limited by them. The meaning of the terms described in this invention should be understood as follows. Terms such as "first" and "second" are intended to distinguish one component from another, and the scope of rights shall not be limited by these terms. For example, the first component may be named the second component, and similarly, the second component may be named the first component. When a component is referred to as being "connected" to another component, it should be understood that it may be directly connected to that other component, or that there may be other components in between. Conversely, when a component is referred to as being "directly connected" to another component, it should be understood that there are no other compo